The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Story
AquariusAPS server receives medical images (EBT, CT, MRI, volumetric/planar) via DICOM protocol; performs automated digital image processing; transmits derived images/data to other DICOM-compliant devices. Functions include: CT table/bony structure removal; centerline calculation for hollow organs/vessels; heart tissue isolation; parametric color overlay mapping for time-dependent scans; sphere-like structure identification; multi-planar/volume rendering (MPR, MIP, VR); image registration; volume calculation. Used in clinical environments; operated by healthcare professionals. Server automates pre-processing tasks to optimize user time, removing need for manual processing on review systems. Output viewed by clinicians on diagnostic workstations to assist in clinical decision-making and diagnostic workflows.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on technical feature comparison and performance of image processing functions consistent with predicate devices.
Technological Characteristics
Hardware: Standard off-the-shelf PC, Pentium III-class processor. OS: Windows 2000. Connectivity: DICOM protocol for image transfer. Processing: Automated image manipulation (MPR, MIP, VR, registration, segmentation). Software: Developed per FDA guidance for software in medical devices. Administration: Browser-based interface.
Indications for Use
Indicated for processing medical images (EBT, CT, MRI, volumetric/planar) received via DICOM protocol to derive new images or information for transmission to other DICOM-compliant devices. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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# 510(k) Premarket Notification
#### AquariusAPS Server Trade Name:
Common/Usual Name: Server for image processing and communication Classification Name: System, Image Processing
MAY 15 2006
#### Establishment Name and Registration Number:
Name: TeraRecon, Inc. Number: 2954793
#### Classification:
21 CFR § 892.2050, Picture Archiving and Communications System, Class II, proposed exempt, final rule pending.
90-LLZ ProCode:
#### Equivalent Device(s):
- 1. Aquarius Workstation-K011142 by TeraRecon Inc.
- 2. AquariusNET Server- K012086 by TeraRecon Inc.
- 3. Lung CAR-K041807 by Medicsight PLC.
- 4. Colon CAR-K042674 by Medicsight PLC.
- 5. Fusion 7D-K020546 by Mirada Solutions, Ltd.
Parts of these devices are substantially equivalent in terms of basic design, features and intended use.
#### Applicant/Sponsor Name/Address:
#### TeraRecon Inc.
2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: (650) 372-1100 FAX: 650-372.1101
#### Contact Person:
Emilly Tojima Quality Assurance and Regulatory Affairs Manager TeraRecon Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: (650) 372-1100
#### Description of the Device:
The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA."
The intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user's time.
K061214
payl-1f2
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### Hardware & Software Information
The AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform. The software requires the use of the Windows 2000 operating system, and a Pentium III - class processor or equivalent.
The software designed to control and manipulate the diagnostic images are based upon information and guidance found in the list of standards provided in Appendix III. In accordance with TeraRecon's software development procedures, the level of concern relative to this software has been determined through information obtained from the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).
| Feature | Aquarius<br>APS | Aquarius<br>NET Server | Aquarius<br>Workstation | Lung CAR<br>Medicsight | Colon CAR<br>Medicsight | Fusion 7D<br>Mirada<br>Solutions |
|------------------------------------------------------------------------------------------------------------------------------|-----------------|------------------------|-------------------------|------------------------|-------------------------|----------------------------------|
| 2D, 3D Image Review | No | Yes | Yes | No | No | No |
| Removal of the CT table<br>from a CT examination | Yes | Yes | Yes | No | No | No |
| Removal of bony structures<br>from a CT examination | Yes | Yes | Yes | No | No | No |
| Calculation of a centerline<br>through a hollow organ or<br>structure, or vessels, for a<br>CT or MR scan | Yes | Yes | Yes | No | No | No |
| Isolation of tissue in the<br>vicinity of and including the<br>heart from a CT scan | Yes | No | Yes | No | No | No |
| Calculation of a parametric<br>color overlay map for time-<br>dependent a MR or CT scan | Yes | No | Yes | No | No | No |
| Identifying locations of<br>sphere-like structures in a<br>CT scan | Yes | No | Yes<br>(Manual) | Yes | Yes | No |
| Calculation of a set of<br>images in certain<br>orientations or planes using<br>MPR, MIP, VR or other<br>rending techniques. | Yes | Yes | Yes | No | No | No |
| Calculation of a<br>transformation to register<br>one set of images to another | Yes | Yes (Manual) | No | No | No | Yes |
| Calculation of the volume<br>of a certain structure,<br>possibly with time<br>dependence | Yes | No | Yes | No | No | No |
| Receiving images using<br>DICOM transfer protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Sending Images and other<br>data using DICOM transfer<br>protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Performing actions based<br>on DICOM tags contained<br>in images received by<br>DICOM | Yes | Yes | No | No | No | No |
| Administration control<br>through a browser-based<br>interface | Yes | Yes | No | No | No | No |
| Export of images and image<br>sequences in a variety of<br>formats | Yes | Yes | Yes | Yes | Yes | Yes |
#### Feature Comparison Table
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
### MAY 15 2005
TeraRecon, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K061214
Trade/Device Name: AquariusAPS Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 1, 2006 Received: May 2, 2006
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" in the center. The logo also includes the years "1906-2006" at the top. There are stars at the bottom of the logo. The text is surrounded by a circular border with additional text.
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
San 1942 2
Enclosure
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### DEVICE NAME: AquariusAPS
### INDICATIONS FOR USE:
The AquariusAPS server receives medical images from medical imaging acquisition devices The Aquartish D server rocercol for image transfer such as EBT, CT, MRI, and other adming to the Droom medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.
Lossy compressed mammographic images and digitized film screen images must not be reviewed LUSS voluptessou interpretations. Mammographic images may only be interpreted using an FDA 101 primal y migrous at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
一次的一个人,一个人生
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
# Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Chroydon
(Division Sign-Off)
Division of Reproductive, Abd and Radiological Devices 510(k) Number
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
